This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.
Once again we have reached the dog-days of summer in Washington DC, when it is nice to day-dream about biotechnology in cooler climates. There may be no better destination for a biotech busman’s holiday than Iceland. (For anyone keeping score, this series also has touched on biotech trends in India,Ireland, Israel (twice) and Italy.)

These days Iceland’s biotechnology sector is enjoying the limelight as one of the ‘Country Spotlights’ in the 2014 Scientific American Worldview on biotechnology released last month at the annual Biotechnology Industry Organization (BIO) Convention in San Diego. The 2014 Worldview highlights the success of Icelandic biotechnology company Sif Cosmetics, which has developed a barley-based cosmetic with anti-aging skin cream, called BIOEFFECT.

Undoubtedly, the collection of Iceland’s comprehensive genetic data would make a further contribution to understanding genetic mutations contributing to a range of public health threats. In the long run, DeCode may be more successful carrying out this important project as a true Public-Private Partnership, ensuring access to the data to Icelandic research institutes as well as private companies on a non-exclusive basis.

About the author:President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

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This is a guest post from Isabela Oliva. Do you have a response to Isabela’s post? Respond in the comments section below.

How to survive the expected and unexpected challenges of the start-up lifecycle in the biotechnology business

A major difference between biotechnology and information technology ventures is the time it takes to bring a product to market. Unlike Facebook and Google, innovation in the medical sciences world generally starts from the results of a long, government-funded basic research investigation.

If a scientific discovery is deemed promising and potentially lucrative, a patent is filed to protect the idea until it matures to a final commercial product. Initially, a patent value is very low due to the high risks and uncertainties associated with the early stage discovery, and it can be hard to attract interest and money from big corporations that have their focus on late stage product development. That is why biotech start-ups emerge. They cover the ground of developing the proof of concept of a new technology.

The early stage of the biotech start-up lifecycle is often called “the translational gap” or “the valley of death”, because of the technical challenges and scarcity of funds available for this early stage of product development. When the proof of concept is successfully established and clinical trials begin, patent value starts to increase, attracting big players in the Biotech/Pharma industry. At this more mature stage of the company, new demands arise, and the start-up company structure and priorities will be required to change in order to survive.

Great technology alone is not sufficient to bring a product from research to market, and leaders should be aware, from the beginning, that a start-up structure and focus will most likely need to change to successfully adapt to the different stages of the product development lifecycle.

This article correlates the different phases of a biotech start-up with the leadership skills necessary to address the most relevant challenges of each stage in an attempt to improve the success rate in surviving “the valley of death”.

Early Stage: The visionary and how to move the idea forward

The spark that ignites the creation of a new biotech start-up is the identification of an opportunity or breakthrough solution for problem in a given market. A passion for the cause, a strong belief in the idea and a clear vision of its application are essential to leadership during the first step of the start-up development.

At this stage, most leaders are the inventors or licensees of an intellectual property. In the early stage the leader must have a strong scientific background and be credible when presenting their idea to the scientific community and the general public. A can-do mentality is crucial, since the number of employees is limited and the leader will need to wear many hats to achieve the company’s goals at this stage, such as defining the technical concepts of the business plan and choosing valuable teammates and partnerships. Understanding the market, protecting intellectual property and securing early funding require a business mind-set, and it can be a challenge for scientists without prior experience outside of the academic world. Nevertheless, being passionate about the technology can help the leader motivate people to believe in the idea, and could also provide the stamina required to overcome the obstacles of the early stage.

Commercialization Stage: The fundraiser and science-to-product

The main goal of this stage is the development of concrete routes for commercialization – assuring sufficient funding to bring a product to the market. The day-to-day operations become more complex, resulting in a need for structured management, and a possibility of changing roles and responsibilities for early stage employees, including co-founders.

Commercial interest will likely replace the early-stage scientific focus as requirements for funding increase. The leader becomes the person with the power to realize the commercial vision for the company. Convincing founders that the priority is commercialization might require canceling projects that seem unprofitable, even if it means shifting the priority to a secondary project that had just entered the pipeline.

It is crucial for the leader at this stage to be strong in their decisions, yet sensitive to the company environment, in order to implement necessary changes without affecting employee relations in a negative way. Communicating and managing change effectively is a key challenge at this stage. A growing biotech start-up cannot afford losing talented employees, many of whom are subject matter experts of the technology being developed. The implementation of professional processes, operations and organizational structures that might make some senior employees uncomfortable will most likely be necessary.

Operational Stage: The strategist and how to deliver

At this stage the company needs to demonstrate its marketability by strengthening alliances, deals, and strategic partnerships. A shift in focus from project to transaction might take place, and the management team might be under pressure from its responsibility to investors and an imminent IPO or M&A. The main company goals are to maximize investor return while maintaining workforce retention, morale and culture. In general, it is a stage when keeping promises to business partners, investors, and the general public is extremely demanding. The leader now needs to lead a result-oriented, precise, and efficient management team, task comparable to those of managers in the large industry. Investors such as Venture Capital might want to bring their own CEO as a leader and take part in the company board of directors.

The Board and Exit Strategy

The board of directors plays a key role in advising the leader at all biotech start-up stages. Although t the leader chooses the board members during the early and commercialization stages, they may lose this control at the operational stage when investors’ pressure on ROI is high. The board generally plays an important role in deciding the exit timing and strategies, and it is the leader’s responsibility to clearly articulate the company’s strategy internally and externally. The ability to successfully react to change and to deal well with pressure is equally important when planning for the exit.

Conclusion

The growth of a biotechnology start-up company presents unique challenges that should be properly addressed to achieve the business goals at each stage. Common leadership skills such as clear communication and the ability to implement change are necessary throughout the biotech start-up lifecycle; however, a transition from a science-oriented to a business-oriented culture seems to be essential to survive “the valley of death”, and must begin within the company’s leadership. The ability to accept change, to adapt and to build and maintain relationships are the key points in the progression from science to business and finally the success of a biotech start-up company.

ABSTRACT: Xenotransplantation, the process of transplanting live cells, tissues and organs from one species into another, is an emerging novel area in medicine. It is proposed as a treatment for human end-stage organ failure and for other applications such as, for example, the treatment of neurodegenerative and liver disorders, meeting the large demand for donor organs...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

This is a guest post from Zhen-Xia Chen. Do you have a response to Zhen-Xia’s post? Respond in the comments section below.

The name of “genomics” originated with the birth of a new journal “Genomics” in 1987. The journal adopted the term genomics for “the newly developing discipline of mapping/sequencing (including the analysis of the information)” [1]. The new discipline was born from “a marriage of molecular and cell biology with classical genetics and is fostered by computational science” [1]. Interestingly, Thomas H. Roderick, who dreamed up the word genomics, came up with the name in a bar when he attended an international meeting in Bethesda. It seems genomics has some connections with National Institutes of Health, whose main campus located in Bethesda, from its beginning [2].

Until 2012, the U.S. government has invested 14.5 billion in genomics [3], and investment from venture capitals is increasing. According to a survey on investment in 72 VC-funded genomics companies from 2006 to 2012, the total investment value increased year by year. Although the number of genomics investments decreased from 22 in 2011 to 16 in 2012, the average genomic investment value increased from $15.1 million in 2011 to $24.5 million in 2012, suggesting that it may be harder for genomics startups to get investment, but the winners would get more investment [4]. In the 72 VC-funded genomics companies, most of them (38/72) have income mainly from research service and equipment [5]. Other companies have main income from health and agriculture applications, including diagnostics (14), drug discovery (7), microbial genomics (6), cancer genomics (5), and agrigenomics (2) [5]. In the period between 2005-2012, US attracted $1.7 billion in funding, while Europe only attracted $213 million. Inside US, California is most attractive to VCs, and have got 1,090 million [6]. Most of top biotech VCs (12/16) have investment in at least one genomics companies, suggesting that genomics is part of a healthy VC investment portfolio [7]. Google ventures, for example, have invested in three genomics companies: DNAnexus, Foundation Medicine and 23andMe [8].

Why VCs are over genomics? The reasons may include its wide applications, fast development and high revenue potentials.

Genomics may have wide applications in agriculture, livestock, ancestry, forensics, bioenergy, and medicine. For example, by identifying, validating and screening of marker genes that present in a plant variety or animal lineage which are associated with desirable traits in an industrial scale, genomics can be used to improve the crops and livestock quicker, better and more cost-effectively than any other technology. In 2013, Monsanto, a leading technology-based agriculture company has partnered with Synthetic Genomics Inc., which was founded to commercialize genomic-driven technologies, to improve crop yields and prevent loss from disease. Genomics can also be applied to discover ancestral origins of a person and trace the lineage with a personalized analysis of his or her DNA. As of March 2014, 23andMe, a personal genomics biotech company that provides genetic testing and interpretation to individual consumers, has genotyped approximately 650,000 individuals.

The potential application of genomics in medicine is great. By identifying the genetic variants of patients, doctors may be able to determine whether a treatment harms or heals [9]. The process from genomic information to clinic includes five steps, including understanding the structure of genomes, understanding the biology of genomes, understanding the biology of disease, advancing the science of medicine and improving the effectiveness of healthcare [10]. Most accomplishments in the HGP period are in the first step. So far, we have found about 60 genetic variants that are deemed worthy for use in clinical care [9]. For example, women with certain variants in the BRCA genes have 80% chance of developing breast cancer, and thus may have preventive mastectomies.

The second appealing feature of genomics for investment is fast development. The development of genomics was greatly facilitated by the Human Genome Project (HGP). HGP, initiated in 1990 and finished in 2003, is an international scientific research with the goal of determining all the sequence, including 3 billion base pairs, of the human genetic instruction set. After HGP, more genomes from other complex organisms (e.g. chicken, mouse, rat, chimpanzee, dog, etc.) have been sequenced, and more projects on human genomics (e.g. ENCODE, which aims at finding out all the functional elements in the human genome; 1000 Genomes, which aims at finding out the variations among human genomes; The Cancer Genome Atlas, which aims at finding genetic mutations responsible for cancer; etc.) have been launched.

DNA sequencing technology, which is the fundamental to genomics, is developing fast. The sequencing of a human genome costs 13 years and $3 billion in HGP, while only 1 day and less than $1000 now. The cost decrease of DNA sequencing has profoundly outraced Moore’s Law (the doubling of “compute power” every two years), indicating exceedingly well improvement of sequencing technology (Figure 1).

Figure 1. Cost of DNA sequening (source: genome.gov

Our knowledge about diseases, including rare diseases caused by single genes, and complex diseases associated with multiple genes, is also developing fast with the development of genomics. It’s estimated that there are ~8400 monogenic diseases, among which ~5100 have known genomic basis. With genome-wide association study (GWAS), genes associated with many complex diseases, e.g. type 2 diabetes, Alzheimer’s disease, autism and breast cancer, have also been found (Figure 2), and genetics tests based on the knowledge can be applied to the diagnosis.

Genomics is also being applied to clinic fast. On Nov. 19, 2013, the U.S. Food and Drug Administration (FDA) allowed marketing of Illumina MiSeqDX sequencer as diagnostic devices. As stated in FDA’s own press release, next-generation sequencing technologies are “becoming more accessible for use by physicians”, and “The new technology also gives physicians the ability to take a broader look at their patients’ genetic makeup and can help in diagnosing disease or identifying the cause of symptoms.” [11]

Figure 2. Published Genome-Wide Associations (source: genome.gov)

The last, and maybe the most, appealing feature of genomics for investment is high revenue potential. It’s reported that every $1 invested in HGP has triggered $178 in US economic activity. The $14.5 billion the US government invested in the human genome effect since 1988 has helped drive $965 billion in economic impact, $293 billion in total personal income and $169 billion increase in economic output since 2010 [12]. In 2012 alone, genomic related research development and commercialization activities generated $65 billion in US economy, 152,314 supported jobs and $18 billion in personal income [12].

Some VC-funded genomics companies have already showed good performance. For example, prenatal DNA sequencing, the noninvasive screening from a syringe of an expecting mother’s blood to discover whether an unborn child has a genetic disorder, was recognized as one of the “10 Breakthrough Technologies 2013” by MIT Technology Review. At least seven companies, including Ariosa, Beijing Berry Genomics, BGI, LifeCodexx/GATX, Natera, Sequenom and Verinata, have developed prenatal tests with the technology [13]. Take Ariosa for example, the price of its Harmony test is $795, and it has sold 150,000 tests from its market entry in May 2012 to September 2013. In other words, Ariosa has got about $120 million by selling the test in 16 months.

In summary, genomics is a promising investment opportunity because of its wide application, fast development and high revenue potential.

References:

1. McKusick V, Ruddle F (1987) A new discipline, a new name, a new journal. Genomics 1: 1.

This article was written by Dr. Zhen-Xia Chen, a postdoctoral visiting fellow at the Laboratory of Cellular and Developmental Biology (LCDB) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/National Institutes of Health (NIH). She received her PhD from the Center for Bioinformatics in the College of Life Sciences of Peking University in China. Besides a Bachelor of Science degree at biotechnology from the College of Life Science and Technology in Huazhong Agricultural University, she also received a Bachelor of Arts degree at Journalism from the School of Journalism and Communication in Wuhan University. She can be reached at chenzhenxia119@gmail.com.

ABSTRACT: This paper looks at the basic law of intellectual property as it applies to a small biotechnology company or start-up. It focuses on the systems and attention to paperwork required so that the company can maximise its intellectual property protection.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

My earlier posting on the BJP victory addressed urgently needed regulatory reforms to restore luster to Indian drugs, devices and clinical research and ensure patient safety domestically and in highly regulated markets alike. For insights into potential patent law priorities – and leaving the important issues of data protection and patent linkage for another day – let’s look back ten years, and revisit the policies of the prior BJP Government.

As full disclosure, I represented the international innovative pharmaceutical industry in a number of developing countries including India in the run-up to the WTO 2005 deadline for adoption of product patent protection. I remember vividly the excitement in the room at the World Economic Forum (WEF) in New Delhi on December 6, 2004 as we awaited remarks of then-Minister of Industry and Commerce Kamal Nath. Speaking to the WEF plenary late in the afternoon, Nath electrified the crowd with his pronouncement that India would not be wishy-washy in meeting its WTO trade obligation to adopt product patents for pharmaceuticals, and that it would be good for India. Three weeks later, Nath ushered in the new era of product patent protection on December 27, 2004 with a detailed policy Statement outlining the rationale behind the BJP’s Ordinance relating to the Patents (Third) Amendment.

Let’s review the pharma / biotech highlights in the Ministry of Commerce and Industry Statement–keeping in mind that the Ordinance was watered-down by leftist amendments before passage in March of 2005 (after the BJP Government was voted out of power).

The pharma and IT industry are described as sunrise sectors for India, increasingly following R&D-based strategies for innovative growth, and dependent on patent protection:

“Thus, while Indian companies spent not even a fraction of a percent on R & D ten years ago, today the larger Indian companies are spending in the region of 6 to 8 percent of their turnover on R & D. (The norm for major MNCs is 12%). The transformed Indian pharma industry is itself looking for patent protection – particularly the bio-tech sector, in which India has aggressive prospects.”

Continued growth of Indian Indian pharma exports to the lucrative US market depended then, as now, on maintaining a patent system consistent with WTO norms:

“When we joined the WTO ten years ago Indian pharma exports were less than 4000 crore rupees. A decade later our pharma exports are 14,000 crore rupees, and account for more than a third of the industry’s turnover. This is the result of the confidence built up in our industry due to our progressive adherence to our IP commitments. Now we are poised to achieve an annual compounded growth rate of 30% in order to double our pharma exports in three years. Some 60 billion dollars worth of drugs are going off patent in the next few years. Indian industry can grab a lion’s share of this – provided we are a bona fide member of the international trading community[.]”

India also stood to gain from adoption of effective patent protection with growth in contract research organizations (CRO) services:

“Apart from manufacture of drugs, the pharma industry offers huge scope for outsourcing of clinical research. We have a vast pool of scientific and technical personnel, and recognized expertise in medical treatment and health care. India can take advantage of our strength in this provided we have the right legal framework in place, which provides IP protection to the results of that research.”

“The fear that prices of medicines will spiral is unfounded. In the first place we must realize the fact that 97% of all drugs manufactured in India are off-patent, and so will remain unaffected. These cover all the life-saving drugs, as well as medicines of daily use for common aliments. In the patented drugs also, in most cases there are always alternatives available.”

The Act sought to balance access, affordability, and conformity with international IP protection norms:

“The Act ensures that the reasonable requirements of the public with respect to availability and affordability are taken care of. Public interest particularly public health and nutrition is protected. The law effectively balances and calibrates Intellectual Property protection with public health concerns and national security. By participating in the international system of intellectual property protection, India unlocks for herself vast opportunities in both exports as well as her potential to become a global hub in the area of R&D based clinical research outsourcing, particularly in the area of bio-technology.”

While hindsight is 20/20, in retrospect the Ministry of Commerce and Industry Statement appears prescient in identifying key stakeholders and the broader social and economic benefits of a product patent protection. Undoubtedly, the BJP Ordinance itself suffered from lacunae – and received significant criticism from the international innovative BioPharma industry. At the same time, the Ordinance was recognized as a critical watershed and a substantial, positive step to move India closer to the patent mainstream. The identified deficits in the BJP Ordinance subsequently were compounded and multiplied by subsequent Leftist amendments, effectively undermining patent protection needed by India’s innovative BioPharma companies and MNCs alike.

Let’s hope that ten years on the Modi Government may see the broader picture beyond price controls for essential medicines and may introduce patent reforms needed to reset the balance between access, affordability and effective patent protection. This would go a long way to meet the BJP Manifesto to support R&D Intensive Small and Medium Sized Enterprises (SMEs) needed for creation and assimilation of new technologies, e.g., novel diagnostics, devices, therapies and cures for patients in India and globally.

About the author:President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

I continue to measure global biotechnology innovation in this sixth edition, which is also the foundation I use for my talks on global biotechnology (see my recent talk on Building Biotechnology in India).

In addition to the comparative global biotechnology innovation scorecard which I edit, Worldview also includes subjective stories of global innovation, highlights of selected countries, and profiles of industry leaders.

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I am seeking input on a new project which helps you identify top-performing patent attorneys.

PatentStat.com uses cutting-edge research on patent strength to identify top-performing patent attorneys and patent firms in 35 technology areas. Attorneys are scored by their average grant time, the number of claims allowed, citations, and other factors.

As an added bonus, PatentStat also profiles patent examiners, creating a tool for patent counsel to better understand their examiner. Average grant times and other metrics for each examiner are posted, helping inform time and financial budgeting decisions.

I will be serving on a panel on June 26th at 12:45-1:45 in Room 3, and David Brancaccio, host of Marketplace Morning Report will be moderating a discussion with industry leaders at 2pm.

In addition to the comparative global biotechnology innovation scorecard which I edit, Worldview also includes subjective stories of global innovation, highlights of selected countries, and profiles of industry leaders.